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The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
Information about how approved bodies help regulate medical devices and how to apply for approval.
An overview of the legal requirements for children鈥檚 medicines that Marketing Authorisation Holders (MAHs) need to abide by.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
Supplementary information for international regulators on packaging changes and the export of UK medicines.
This guidance covers 鈥榞randfathering鈥� and managing the lifecycle changes of medicinal products.
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
If pharmacies wish to 鈥榩ack down鈥� larger packs of a medicinal product, they need to follow these instructions
Industry must notify the MHRA if they will not be using these flexibilities
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